Noven Pharms., Inc. v. Watson Labs., Inc.

Case Name: Noven Pharms., Inc. v. Watson Labs., Inc., C.A. No. 11-cv-5997 (DMC)(JBC), 2013 U.S. Dist. LEXIS 167902 (D.N.J. Nov. 26, 2013) (Cavanaugh, J.) (On summary judgment, asserted claims held invalid for lack of written description; summary of non-infringement granted.)

Drug Product and Patent(s)-in-Suit: Daytrana® (methylphenidate); U.S. Patent Nos. 6,210,705 (“the ’705 patent”) and 6,348,211 (“the ’211 patent”)

Nature of the Case and Issue(s) Presented: Defendants assert that the ’705 patent claims containing the 5 wt % limitation are invalid because those claims lack sufficient written description. The court construed the 5 wt % limitation as referring to the amount of acid functional monomers by the weight of the monomer content, but the ’705 patent specification refers to the amount of acid functional monomers by weight of acrylic monomer. Essentially, defendants argue that the invention claimed is broader than the invention described in the specification. Plaintiff then argued that the court should rule against defendants because it already rejected defendants’ written description arguments when it adopted plaintiff’s construction of the wt % limitations after the Markman hearing. Plaintiff also relied on the ’705 patent specification that shows that the degradation of methylphenidate is reduced by minimizing acid functional groups, regardless of the source, and discloses that the degradation of methylphenidate increases with each 1% increase of acid functional component. Third, plaintiff relies on the fact that the ’705 patent specification includes the original claims filed, which “demonstrate ample written description beyond the specific preferred 5 wt % acrylic embodiment.” Finally, plaintiff relies on language in the ’705 patent specification that it shows that a 5 wt % functional acrylic polymer is only a preferred embodiment.

Regarding the ’211 patent, defendants argued that they do not infringe because all dosage strengths of the Watson ANDA product include methylphenidate:silicone adhesive:acrylic adhesive (wt % dry) in the following proportion: 21:0:79. Thus, defendants argue that because this court found that the term “about” in the proportion limitation only allows for the rounding of decimals to whole numbers, the 79% acrylic adhesive present in the Watson ANDA product does not literally fall within the “0-70” claimed range for the acrylic adhesive required by the proportion limitation. Plaintiff contends that the terms “proportion” and “ratio” refer to the total weight of the composition (which includes components other than methylphenidate, silicone adhesive, and acrylic adhesive). Therefore, according to plaintiff, because the Watson ANDA product contains 18.3 % methylphenidate and 68.7 % acrylic adhesive, it literally infringes the ’211 patent claims.

Defendants’ summary-judgment motion of invalidity of the ’705 patent was granted, while plaintiffs’ summary-judgment motion of no invalidity of the ’705 patent was denied; defendants’ motion for partial summary judgment of non-infringement of the ’211 patent was granted.

Why Defendants Prevailed: The language in the ’705 patent specification that plaintiffs rely on, although it describes the effect of reducing acid functional groups in general, does not provide any blaze marks that would lead a person of ordinary skill to compositions having no more than 5 wt % acid functional monomers by weight of the total monomer content. In response to plaintiffs’ “original claims” argument, the court found that the USPTO examiner rejected those claims as “not reasonably provid[ing] enablement for a composition wherein the amounts and proportions are not claimed,” leaving a person of ordinary skill unable to obtain the “desired flux rate for the desired period of time” based on the patent’s teachings. Lastly, in response to plaintiffs’ “preferred embodiment” argument, the court found that the relied-on language does nothing to suggest that a person of ordinary skill would appreciate the existence of any other embodiment.

As for the ’211 patent, the court found no support for the proposition that the terms “proportion” and “ratio” refer to the entire composition rather than to the dry weight of the three components. Plaintiff’s expert admitted that “Watson’s ANDA Products contain a slightly different ratio of methylphenidate:silicone adhesive:acrylic adhesive (wt % dry), namely the ratio of 21%:0%:79%,” and went on to assert that the use of 79% acrylic adhesive in the Watson ANDA product is nonetheless equivalent to the proportion limitation under the doctrine of equivalents. Further, the language used by plaintiff throughout the case shows that plaintiff understood that “proportion” refers to the ratio of the three components based on their combined dry weight, not the weight of the entire composition.